NCT02642198

Non-Invasive Blood Pressure Monitor Accuracy in Neonatal Subjects

Clinical Investigation for Non-invasive Blood Pressure Monitor Accuracy Validation Performed on Neonatal, Infants and Children up to 3 Years Old

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Mortara Instrument · Industry
• Sex: All
• Age: 29 Days – 3 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to validate the accuracy of non-invasive blood pressure (NIBP) measurement technology from Mortara Instrument, Inc. (Milwaukee, Wisconsin, USA) and Zoe Medical, Inc. (Topsfield, Massachusetts, USA) in a neonatal, infants and children up to 3 years old patient population. The study is defined according to the International Standard "ANSI/AAMI/ISO 81060-2:2013, Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type".

Detailed description

The device under test is Mortara Instrument's Surveyor S12/S19 patient monitors ("Surveyor") incorporating neonatal NIBP technology. Specifically, NIBP measurements will be taken using a cuff on the patient's limb (exact location will be determined by clinician) using a variety of cuffs sized for neonates and pediatrics. The device utilizes oscillometric technology to obtain quickly and conveniently non-invasive blood pressure measurements. Results will be compared to invasive blood pressure measurements from patients already monitored with such sensors. The Device under Test will be calibrated and verified by a Mortara representative on site.

Conditions

• Non-invasive Blood Pressure

Interventions

Type	Name	Description
DEVICE	Surveyor S12 and S19 patient monitor	Non-invasive blood pressure measurement

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-03-01
• First posted: 2015-12-30
• Last updated: 2016-03-23

Locations

2 sites across 1 country: Italy